An unstinting focus on quality is the cornerstone of everything we do at Exeltis India. Quality is the heart of our company. Our organizational values are weaved by the principles of “one quality voice”. Trust, commitment, Responsibility, Sustainability and growth are the pillars of this ideology. Our Quality Assurance & Quality Control processes and methodologies are critical to the successful development, manufacture and distribution of our drugs that improve health outcomes and even save lives of people worldwide.

QUALITY ASSURANCE

Our QA systems are planned and executed in a way that ensures the requirements for high-quality product development are fulfilled for every product, every time. Compromise is not an option for us!

During QA, we establish standards and benchmarks, create documentation to encompass incident reporting, deviations and change controls with CAPA, and conduct internal audits to ensure continued compliance. Critical QA tools like Facility, Equipment and Vendor qualification, Product Release, Trend Analysis, Self-inspection, Market complaint, Product recall, Out of specification, Out of trend and Annual Quality Review are essential elements of our Quality Management System. They are conceived and Implemented as per global requirements and standards.

• Dedicated Air Handling Units for each process area prevent cross contamination
• AHU validation parameters like filter integrity test, airflow pattern, recovery, particle count, air-changes and air velocity are established during validation and reviewed during regular revalidation to ensure that we continue to meet environmental monitoring quality norms

QUALITY CONTROL

The Quality Control system is at the heart of our entire quality process. We have exclusive chemical labs, instrumentation and microbiology labs to test not only APIs (Active Pharmaceutical Ingredients), excipients and finished drug products; but also packaging and in-process materials. Highly-skilled QC professionals perform regular inspections on products and conduct tests to determine whether the requirements highlighted during QA implementation are properly executed during production.

• QC is always carried out as per the norms of Good Laboratory Practices (GLP) that ensure unwavering quality and integrity of studies and tests
• The QC lab is furnished with sophisticated, ultra-modern and in some cases, automated apparatus such as UV Spectrophotometer, GC, HPLC, FTIR, auto-titrator and TOC analyser
• A dedicated, classified microbiology area is set up for microbial analysis and periodical monitoring to achieve environmental compliance as per Good Manufacturing Practice (GMP) norms
• Three walk-in stability chambers (each with a capacity of 8000 litres as per ICH specification) ensure continuous review of stability data throughout the shelf life of each product
• A 24/7 air-conditioned retention sample room ensures each batch of products is stored under prescribed storage conditions. This enables us to carry out quality audits at any time with ease